Associate Director/Director of Medical Affairs

Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate. 

At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges. 

Biofidelity’s core values are Humanity- care & compassion; respecting personal lives; humour. Openness- sharing research; experimental approach; permission to fail. High expectations- be fearless; make a difference; willingness to do what’s needed. Our core values define our company culture, they are shared values, goals, attitudes and practices that characterise Biofidelity employees. We are looking for likeminded people to join the Biofidelity team.

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision coverage, 401(k), bonus, stock options, life insurance,  short-term and long-term disability income protection, 20 vacation days and 5 sick days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

Biofidelity is looking for a dynamic, efficient and results-oriented Associate Director/Director of Medical Affairs with a strong background in oncology molecular diagnostics to support the planning, development and execution of our medical affairs strategy.  This position reports to the VP of Medical Affairs.

Key responsibilities:

●      Lead Global KOL and SAB engagement to support clinical and commercial objectives by representing Biofidelity in regional and national scientific conferences, advisory meetings, webinars and 1:1 discussions.  

●      Provide strategic and hands-on internal and external executional leadership for the medical affairs function to support our molecular oncology products

●      Provide clinical support for regulatory and reimbursement

●      Partner with commercial team in building engagement with leading key opinion leaders including oncologists, pathologists, pulmonologists, patient advocacy groups, diagnostic laboratories, contract research organizations and pharma as we create strategies for product development, reimbursement, innovation, evidence generation and research

●      Clinical leadership for publication strategy and reference library management to support clinical engagement and commercial requirements  

●      Serve as a clinical leader in aggregating scientific, medical and technical customer-focused insights and strategic perspectives related to molecular diagnostic oncology products and initiatives 

●      Align with brand and launch team on cross-functional team representation with the goal of developing and implementing integrated clinical and commercial strategies for Biofidelity’s products to enhance our corporate image and increase understanding of Biofidelity’s oncology/molecular clinical applications 

●      Based on product priorities and research strategies, establish, and drive a clinical and scientific agenda, by engaging researchers through Biofidelity’s activities and partnerships, including conducting studies that lead to publications in support of Biofidelity’s product objectives

●      Coordinate and lead advisory boards and round tables to gather clinical insights to enable the sharing of clinical knowledge with and between internal and external stakeholders

●      Lead medical review and provide input on promotional and other materials in accordance with appropriate regulations

●      Provide clinical input and oversight for clinical trial design, implementation, and data interpretation to support product development and regulatory approval

●      Support customer service in our CLIA lab

●      Support tumor bank tissue planning and acquisition 

Knowledge, Skills, And Abilities:

●      Technical and working knowledge of the basics of molecular pathology, cancer genomics and oncology diagnostics  

●      Knowledge of NGS, liquid biopsy and other genomic testing modalities

●      Clinical knowledge of NSCLC practice guidelines and the ability to adapt and apply similar expertise to other oncology and disease areas as the portfolio expands

●      Knowledge of publication best practices, management of reference library, and ability to lead publication strategy 

●      Knowledge of oncology and molecular diagnostics,  pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to clinical operations, commercial, translational,  regulatory, and medical affairs

●      Understanding of compliance between commercial and clinical functions,  RUO vs LDT 

●      Demonstrated experience with leadership in stakeholder engagement (e.g., KOLs, advocacy groups, payers, regulatory authorities)

●      Understanding of patient advocacy and engagement to incorporate patient-centric insights into clinical and commercial strategies 

●      Outstanding written and verbal communication skills

●      Strategic thinker with ability to focus on specific tactical needs and operational side of the role as we build the team

●      High degree of self-motivation and ability to work independently, willingness to work in a dynamic start-up environment

●      Solution-oriented, result driven, with strong attention to detail

●      Demonstrated experience working cross-functionally and collaboratively across different teams and geographies

●      Cross-cultural awareness, ability to thrive in a small, dynamic and rapidly growing company environment

●      Ability to travel up to 30% time

Requisite Education and Experience/Minimum Qualifications:

●      MD and 1+ year of Medical Affairs or related pharmaceutical industry experience in medical device, oncology genomic diagnostics  

●      OR PhD molecular pathologist OR other advanced clinical degree, with equivalent and relevant medical training  and 2 + years of Medical Affairs experience pharmaceutical industry experience including launch and lifecycle management

●      Medical Affairs or related experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with healthcare providers,  integrated delivery networks, accountable care organizations, and/or payers

The expected, full-time, annual base salary range for this position is $140,000-$190,000. The actual base salary will vary based on factors including qualifications, experience and location. At Biofidelity, we take a market-based approach to compensation to ensure we are objective, equitable and competitive.